GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Valganciclovir Tablet USP 450mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Valganciclovir Tablet USP 450mg
Each film-coated tablet contains:
Valganciclovir Hydrochloride USP
Eq. to Valganciclovir ……….450mg
Excipients…………………….…………q.s.
Colour: Titanium Dioxide IP
Each film-coated tablet contains:
Valganciclovir Hydrochloride USP
Eq. to Valganciclovir ……….450mg
Excipients…………………….…………q.s.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (eg, heart, kidney, or kidney-pancreas transplant. This indicated is for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).
CAUTION & SCHEDULE:
CAUTION: DISPANCE IN A TIGHT, LIGHT-RESISTANCE, CONTAINER.
DO NOT BREAK OR CRUSH TABLET
NOT FOR SALE WITHOUT PRESCRIPTION
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription Nephrologist/ specialist only.
DO NOT BREAK OR CRUSH TABLET
NOT FOR SALE WITHOUT PRESCRIPTION
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription Nephrologist/ specialist only.
STORAGE & DOSAGE:
STORAGE: Keep in cool & Dry place.
Protect from Light & moisture.
Temperature not exceeding 30°C.
Preserve in tight container.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.
Protect from Light & moisture.
Temperature not exceeding 30°C.
Preserve in tight container.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.
Valganciclovir Tablet USP 450mg Technical Specification:
| Product Name: | Valganciclovir Tablet USP |
| Brand Name: | Valcytaj |
| Strength: | 450mg |
| Dosage Form: | Film-coated Oral Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 2s, 4s, 10s, 60S |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-viral & Treatment of CMV |
| Indication: | Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent, maintenance & treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). |
| Storage: | Keep in cool & Dry place. Protect from Light & moisture. Temperature not exceeding 30°C. Preserve in tight container. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Valganciclovir Tablet USP 450mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Valganciclovir Tablet USP 450mg
Each film-coated tablet contains:
Valganciclovir Hydrochloride USP
Eq. to Valganciclovir ……….450mg
Excipients…………………….…………q.s.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (eg, heart, kidney, or kidney-pancreas transplant. This indicated is for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).
CAUTION & SCHEDULE:
CAUTION: DISPANCE IN A TIGHT, LIGHT-RESISTANCE, CONTAINER.
DO NOT BREAK OR CRUSH TABLET
NOT FOR SALE WITHOUT PRESCRIPTION
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription Nephrologist/ specialist only.
STORAGE & DOSAGE:
STORAGE: Keep in cool & Dry place. Protect from Light & moisture. Temperature not exceeding 30°C.
Preserve in tight container.
Keep medicine out of reach of children.
Read enclosed leaflet before use.
Dosage: As Directed by the Physician.
